The FDA import alert broadens the scope of a 2025 import action covering dozens of endoscopes and comes two weeks after a new warning letter identified numerous quality system violations.

The Food and Drug Administration said Tuesday it is preventing five more models of Olympus endoscopes manufactured in Japan from being shipped into the U.S., adding to a list of 58 devices already denied entry under a June 2025 import alert.

The update follows an Oct. 7 warning letter in which the FDA detailed violations of quality system regulations and medical device reporting requirements after inspecting six Olympus facilities.

An Olympus spokesperson said in an email to MedTech Dive that the company is treating the warning letter and import alerts as a top priority.

The FDA letter to healthcare providers on imports broadens the scope of the 2025 alert to include certain enteroscopes and ingestible telemetric gastrointestinal capsule imaging systems. The agency said it continues to have concerns related to outstanding quality system regulation violations “despite extensive and ongoing efforts to address compliance issues.”

In total, items refused entry into the U.S. include devices to perform diagnostic and therapeutic procedures in the urinary and respiratory tracts, abdomen, pelvis and small intestine, as well as automated endoscope reprocessors. Some of the devices may have been recalled, the FDA said.

Devices subject to the alert but currently in use may continue to be operated if users are not experiencing problems with them, the agency said.

In a separate statement , Olympus said it does not expect the import alerts to have any material impact on customers or incremental effects on its consolidated financial results for the fiscal year ending March 31, 2027.

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